Nimodipine Stadafarma 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nimodipine Stadafarma 30 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Nimodipine Stadafarma is and what it is used for.
2. What you need to know before taking Nimodipine Stadafarma.
3. How to take Nimodipine Stadafarma.
4. Possible side effects.
5. How to store Nimodipine Stadafarma.
6. Contents of the pack and other information.

1. What Nimodipino Stadafarma is and what it is used for

Nimodipino Stadafarma is a medicine that contains a substance called nimodipine and belongs to a group of medicines known as calcium antagonists. These substances are capable of dilating arteries and preventing them from constricting, thereby avoiding oxygen deficiency in the brain.

Nimodipine is used for the prevention of neurological damage caused by inadequate blood supply, resulting from constriction of cerebral arteries following a subarachnoid haemorrhage (a type of brain bleed caused by the rupture of an aneurysm, which is an abnormal bulging or weakening in the wall of a portion of an artery).

2. What you need to know before taking Nimodipine Stadafarma

Do not take Nimodipine Stadafarma

• If you are allergic (hypersensitive) to nimodipine or to any of the other ingredients of this medicine listed in section 6.
• If you are taking any of the following medicines for epilepsy: phenobarbital, phenytoin, or carbamazepine.
• If you are taking rifampicin (an antibiotic used to treat tuberculosis).
• If you have severe liver disease (e.g., cirrhosis).
  • If you have generalized cerebral edema (increased fluid in the brain).
  • If you have severe intracranial hypertension (markedly increased pressure inside the skull).

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine.

• If you have blood pressure disorders or are being treated to lower your blood pressure.
• If you have kidney or liver disease.
• If you have suffered a head injury causing intracranial bleeding.
• If you have heart problems, e.g., cardiac arrhythmias or heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs). In such cases, your doctor will perform periodic monitoring.
• If you weigh less than 70 kg.

In all these situations, your doctor should carry out a series of checks to appropriately adjust your nimodipine dose.

If you are being treated with any of the medicines mentioned in the section "Taking Nimodipine Stadafarma with other medicines," your doctor will monitor your blood pressure and adjust your nimodipine dose accordingly.

Taking Nimodipine Stadafarma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with this medicine; in such cases, your doctor may need to adjust the dose or discontinue treatment with one of the medicines. This is especially important when taking:

• Rifampicin (a medicine used to treat tuberculosis), as it may reduce the effectiveness of nimodipine (see section "Do not take Nimodipine Stadafarma").
• Medicines for epilepsy such as phenytoin, phenobarbital, or carbamazepine, if previously taken chronically before starting nimodipine (see section "Do not take Nimodipine Stadafarma").
• Medicines to lower blood pressure, as they may enhance the hypotensive effect of nimodipine.
• Cimetidine (a medicine used in the management of stomach ulcers) or valproic acid (used in the treatment of epilepsy), as they may enhance the hypotensive effect of nimodipine.
• Antibiotics (medicines used to treat infections) such as erythromycin, quinupristin, and dalfopristin.
• Antiretroviral medicines (used to treat HIV infection) such as ritonavir and zidovudine.
• Antifungal medicines (used to treat fungal infections) such as ketoconazole.
• Medicines for depression such as nefazodone, fluoxetine, and nortriptyline.

Taking Nimodipine Stadafarma with food and drink

Grapefruit juice should not be consumed together with nimodipine, as it may alter the medicine's effectiveness. Nimodipine should be taken apart from meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Nimodipine should not be used during pregnancy or breastfeeding unless prescribed by a doctor. If its use is considered essential, your doctor will assess whether this medicine should be administered.

Driving and using machines

If you feel dizzy after taking nimodipine, you should not drive or operate machinery. This is particularly important if you consume alcohol during treatment; therefore, alcohol consumption should be avoided during treatment.

3. How to take Nimodipine Stadafarma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose to prevent neurological damage due to reduced blood flow caused by constriction of the cerebral arteries after a subarachnoid haemorrhage is (after an initial infusion of nimodipine 0.2 mg/ml solution for infusion for 5 to 14 days) a daily dose of 2 tablets of this medicine 6 times a day (6 times x 60 mg of nimodipine daily), for a total maximum period of approximately three weeks. The interval between doses should not be less than four hours.

In general, the tablet should be swallowed whole without chewing, with a little liquid (e.g., a glass of water), except grapefruit juice. Nimodipine should be taken on an empty stomach (see section “Taking Nimodipine Stadafarma with food and drink”).

Liver disease: You must not take this medicine if you have severe liver disease (see section “Do not take Nimodipine Stadafarma”). Inform your doctor if you have or have had any liver disease so that your doctor can adjust the dose appropriately.

Kidney disease: Inform your doctor if you have or have had any kidney disease, as it may be necessary to adjust the dose of nimodipine.

Use in children and adolescents: The use of nimodipine in children and adolescents is not recommended.

Your doctor will determine the duration of treatment with nimodipine. Do not stop the treatment prematurely or abruptly, as this could be harmful to the progression of your condition.

If you take more Nimodipine Stadafarma than you should

If you have taken more nimodipine than you should, contact your doctor or pharmacist immediately.

The symptoms you may experience include: marked decrease in blood pressure, increased or decreased heart rate, gastrointestinal disturbances (e.g., nausea), and effects on the central nervous system.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Nimodipine Stadafarma

Do not take a double dose to make up for missed doses.

If you forget a dose, take the tablet as soon as possible and continue the treatment as prescribed. However, if it is almost time for the next dose, it is better not to take the missed tablet and to take the next one at the scheduled time.

If you stop taking Nimodipine Stadafarma

If you have any questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects, more or less bothersome, occur in some patients, especially at the beginning of treatment.

The following possible adverse effects have been reported:

Common (may affect up to 1 in 10 people)

• hypotension (low blood pressure), vasodilation (widening of blood vessels)
• indigestion, abdominal cramps
• dermatitis, rashes, acne
• muscle cramps

Uncommon (may affect up to 1 in 100 people)

• hot flushes
• changes in heart rate: bradycardia (decrease), tachycardia (increase), palpitations, heart failure
• anemia, decreased platelet count in blood
• peripheral edema (swelling of legs or hands), fainting, bruising, vasoconstriction (narrowing of blood vessels), increased blood pressure, thrombosis
• diarrhea, constipation, vomiting, flatulence, gastrointestinal bleeding
• headache, dizziness, involuntary movements, tremor, depression, sweating
• difficulty breathing
• itching, urticaria, petechiae (small purplish spots)
• allergic reaction
• hepatitis, jaundice (yellowing of skin and mucous membranes)

Rare (may affect up to 1 in 1,000 people)

• decreased sodium levels in blood
• ileus (intestinal obstruction)
• increased liver enzyme levels indicating liver function (including increased alkaline phosphatase and lactate dehydrogenase)

Frequency not known (cannot be estimated from available data)

• nausea
• decreased blood pressure, especially when baseline values are high, increased gamma-glutamyltransferase, elevated transaminases (a type of liver enzyme indicating liver function)
• low oxygen levels in body tissues

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report it directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Nimodipine Stadafarma

Keep this medicine out of the sight and reach of children.

Remove the tablet from the original packaging immediately before administration.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nimodipine Stadafarma

• The active substance is nimodipine. Each coated tablet contains 30 mg of nimodipine.
• The other components are microcrystalline cellulose (E-460), pregelatinized corn starch, crospovidone, povidone (E-1201), magnesium stearate (E-572), hydroxypropylmethylcellulose, polyethylene glycol 400, titanium dioxide (E-171).

Appearance of the product and contents of the pack

The coated tablets are white or slightly yellowish, round, biconvex, with a score line on one side and the letter B on the opposite side. Free from visible impurities.

Nimodipine Stadafarma 30 mg film-coated tablets are available in packs of 30 and 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona), Spain

[email protected]

Manufacturer:

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26

28850 Torrejón de Ardoz (Madrid), Spain

Date of the most recent review of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.